Kidney StonesRIRS-VENTNCT07705646
Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery
A study testing Standard Ventilation, Hypoventilation and Intermittent Apnea Ventilation in people with Kidney Stones and Nephrolithiasis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial will compare four ventilation strategies during retrograde intrarenal surgery performed under general anesthesia. The study aims to determine whether reducing respiratory-related kidney movement improves surgical success and decreases perioperative complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stones, Nephrolithiasis
- What is being tested?
- Standard Ventilation, Hypoventilation and Intermittent Apnea Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years. ASA physical status I-III. Scheduled for elective RIRS/RIRC under general anesthesia. No obstructive or restrictive pulmonary disease. No history of pneumothorax. No pulmonary mass or other significant respiratory disease. Normal coagulation parameters and not receiving antithrombotic therapy. No active urinary tract infection. Written informed consent.
Who cannot join
- Age <18 or >75 years. ASA IV. Obstructive or restrictive pulmonary disease. History of pneumothorax. Pulmonary mass or significant respiratory disease. Receiving antithrombotic therapy or abnormal coagulation. Active urinary tract infection or urinary tract anatomical abnormality. Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Istanbul, 34668
Tuna Ertürk, MD, +905325010066, tunaerturk22@yahoo.com
Hakan Emirkadı, MD, 05322609367, hemirkadi@gmail.com
About this study
Official title: Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
This randomized clinical trial will compare four ventilation strategies during retrograde intrarenal surgery performed under general anesthesia. The study aims to determine whether reducing respiratory-related kidney movement improves surgical success and decreases perioperative complications. Eighty adult patients will be randomly assigned to standard ventilation, hypoventilation, intermittent apnea ventilation, or one-lung ventilation. Surgical outcomes and perioperative complications will be compared between groups.
Read the detailed description
Retrograde intrarenal surgery is commonly performed under general anesthesia, but respiratory movement may interfere with kidney stability during the procedure. This prospective, randomized, single-center trial will compare standard ventilation, hypoventilation, intermittent apnea ventilation, and one-lung ventilation in adult patients undergoing retrograde intrarenal surgery. The primary objective is to determine whether different ventilation strategies improve surgical success by reducing kidney movement. Secondary outcomes include operative time, stone access time, fluoroscopy time, laser use time, complications, length of hospital stay, and postoperative stone-free rate.
- Conditions
- Kidney Stones, Nephrolithiasis
- Being tested
- Standard Ventilation, Hypoventilation, Intermittent Apnea Ventilation, One-Lung Ventilation
- Keywords
- Retrograde Intrarenal Surgery, RIRS, Mechanical Ventilatio, General Anesthesia, Kidney Motion
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard VentilationProcedure or surgery
Volume-controlled mechanical ventilation using standard ventilator settings during general anesthesia.
HypoventilationProcedure or surgery
Volume-controlled mechanical ventilation using reduced tidal volume and respiratory rate during general anesthesia.
Intermittent Apnea VentilationProcedure or surgery
Intermittent apnea periods applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.
One-Lung VentilationProcedure or surgery
One-lung ventilation applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.
| Study group | Role | What they receive |
|---|---|---|
| Standard Ventilation | Active comparator | Patients will receive standard volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia. Receives: Procedure: Standard Ventilation |
| Hypoventilation | Experimental | Patients will receive hypoventilation with reduced tidal volume and respiratory rate during retrograde intrarenal surgery under general anesthesia. Receives: Procedure: Hypoventilation |
| Intermittent Apnea Ventilation | Experimental | Patients will receive intermittent apnea periods during selected surgical steps, in coordination with the surgeon. Receives: Procedure: Intermittent Apnea Ventilation |
| One-Lung Ventilation | Experimental | Patients will receive one-lung ventilation during selected surgical steps, in coordination with the surgeon. Receives: Procedure: One-Lung Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Motion During Retrograde Intrarenal Surgery
Kidney motion during surgery will be evaluated and compared among the four ventilation strategies.
Measured: During surgery
Secondary outcomes (6)
Stone-free Rate
Percentage of patients who are stone-free after retrograde intrarenal surgery.
Measured: Postoperative Day 30
Operative Time
Total duration of surgery measured from the beginning to the end of the surgical procedure.
Measured: During surgery
Fluoroscopy Time
Total fluoroscopy exposure time recorded during the procedure.
Measured: During surgery
Laser Activation Time
Total duration of laser use during stone fragmentation.
Measured: During surgery
Perioperative Complications
Occurrence of intraoperative and postoperative complications.
Measured: Periprocedural
Length of Hospital Stay
Number of days of hospitalization.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of four parallel ventilation strategy groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuna Erturk, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Tuna Ertürk, MD, Principal investigator, University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705646
- Sponsor's protocol ID
- 21-64
- Acronym
- RIRS-VENT
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07705646
- Acronym / sponsor ID
- RIRS-VENT / 21-64
- Conditions
- Kidney Stones, Nephrolithiasis
- Keywords
- Retrograde Intrarenal Surgery, RIRS, Mechanical Ventilatio, General Anesthesia, Kidney Motion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will compare four ventilation strategies during retrograde intrarenal surgery performed under general anesthesia. The study aims to determine whether reducing respiratory-related kidney movement improves surgical success and decreases perioperative complications. Eighty adult patients will be randomly assigned to standard ventilation, hypoventilation, intermittent apnea ventilation, or one-lung ventilation. Surgical outcomes and perioperative complications will be compared between groups.
Detailed description
Retrograde intrarenal surgery is commonly performed under general anesthesia, but respiratory movement may interfere with kidney stability during the procedure. This prospective, randomized, single-center trial will compare standard ventilation, hypoventilation, intermittent apnea ventilation, and one-lung ventilation in adult patients undergoing retrograde intrarenal surgery. The primary objective is to determine whether different ventilation strategies improve surgical success by reducing kidney movement. Secondary outcomes include operative time, stone access time, fluoroscopy time, laser use time, complications, length of hospital stay, and postoperative stone-free rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four parallel ventilation strategy groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Ventilation | Active comparator | Procedure: Standard VentilationPatients will receive standard volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia. |
| Hypoventilation | Experimental | Procedure: HypoventilationPatients will receive hypoventilation with reduced tidal volume and respiratory rate during retrograde intrarenal surgery under general anesthesia. |
| Intermittent Apnea Ventilation | Experimental | Procedure: Intermittent Apnea VentilationPatients will receive intermittent apnea periods during selected surgical steps, in coordination with the surgeon. |
| One-Lung Ventilation | Experimental | Procedure: One-Lung VentilationPatients will receive one-lung ventilation during selected surgical steps, in coordination with the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-75 years. ASA physical status I-III. Scheduled for elective RIRS/RIRC under general anesthesia. No obstructive or restrictive pulmonary disease. No history of pneumothorax. No pulmonary mass or other significant respiratory disease. Normal coagulation parameters and not receiving antithrombotic therapy. No active urinary tract infection. Written informed consent.
Key exclusion criteria (1 listed)
- Age <18 or >75 years. ASA IV. Obstructive or restrictive pulmonary disease. History of pneumothorax. Pulmonary mass or significant respiratory disease. Receiving antithrombotic therapy or abnormal coagulation. Active urinary tract infection or urinary tract anatomical abnormality. Refusal or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard VentilationVolume-controlled mechanical ventilation using standard ventilator settings during general anesthesia. | Procedure or surgery | Standard Ventilation |
| HypoventilationVolume-controlled mechanical ventilation using reduced tidal volume and respiratory rate during general anesthesia. | Procedure or surgery | Hypoventilation |
| Intermittent Apnea VentilationIntermittent apnea periods applied during selected stages of retrograde intrarenal surgery to reduce kidney motion. | Procedure or surgery | Intermittent Apnea Ventilation |
| One-Lung VentilationOne-lung ventilation applied during selected stages of retrograde intrarenal surgery to reduce kidney motion. | Procedure or surgery | One-Lung Ventilation |
Primary outcome
Kidney Motion During Retrograde Intrarenal Surgery
Time frame: During surgery
Kidney motion during surgery will be evaluated and compared among the four ventilation strategies.
6 secondary outcomes
Stone-free Rate
Time frame: Postoperative Day 30
Operative Time
Time frame: During surgery
Fluoroscopy Time
Time frame: During surgery
Laser Activation Time
Time frame: During surgery
Perioperative Complications
Time frame: Periprocedural
Length of Hospital Stay
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuna Ertürk, MD principal investigator
University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Ventilation, Hypoventilation and Intermittent Apnea Ventilation in people with Kidney Stones and Nephrolithiasis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuna Ertürk, MD (+905325010066, tunaerturk22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Motion During Retrograde Intrarenal Surgery (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.